Hemiplegia, Perinatal Brain Injury
Conditions
Keywords
constraint induced movement therapy, infants, taVNS, sTMS, hemiplegia
Brief summary
Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.
Detailed description
One of the most effective early therapies for improving motor skills in infants with unilateral motor weakness after perinatal brain injury, is constraint induced movement therapy (CIMT), in which a therapist engages a child in targeted play therapy with the more-affected arm/hand while the less-affected arm is immobilized in a mitt, reinforcing activity-dependent neuroplasticity. taVNS may accelerate functional gains and boost CIMT effects in young infants with hemiplegia over CIMT alone, based on pilot data. Before embarking on a larger scale trial, single pulse transcranial magnetic stimulation (sTMS) will be used to determine the connectivity and strength of the cortical spinal tract motor circuit with motor evoked potential of the hand or thumb. The hypothesis is that the ability to respond to taVNS paired with intensive motor skill therapy in hemiplegic infants may be predicted by motor evoked potentials (MEP) elicited from sTMS over the motor cortex, as a quantifiable biomarker of CST circuit integrity, circuit response and cortical excitability.
Interventions
DEVICEsTMS
Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials
DEVICEtaVNS
taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The trial is designed to use a diagnostic device prior to using an experimental treatment device paired with non-experimental physical therapy (CIMT).
Eligibility
Sex/Gender
ALL
Age
8 Months to 24 Months
Healthy volunteers
No
Inclusion criteria
* Infants 8-24mo with hemiplegia or asymmetric weakness of one arm, with or without truncal and transitional motor delays * Gross Motor function Classification system (GMFCS) I - IV * Parents are able to make consecutive appointments for assessments and intervention over 2wks and complete the 3mo follow-up. * Parents are willing to fill out developmental questionnaires and provide the study team feedback on tolerability and outcomes.
Exclusion criteria
* previous CIMT within 3 months * GMFCS V or severe motor impairment/quadriplegia * uncorrected blindness/deafness, cardiomyopathy * poorly controlled seizure disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assisted Hand Assessment | 3months | Percent Change in the mini-AHA or AHA from baseline to end of treatment- the standardized scale on the Assisted hand assessments range from 0-100 where 100 indicates greatest possible functional use of the hand and 0 indicates no hand function |
| Motor Evoked Potential (MEP) | 3 months | Presence or absence (+ or -) of MEP in the affected upper extremity in response to sTMS of primary motor cortex in both hemispheres (circuit analysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMFM-88 | 3 months | Percent Change in scores of Gross motor function measure-88 from baseline to end of treatment; total raw scores range from 0-264, with higher scores indicating greater motor function |
Countries
United States
Contacts
Primary ContactDorothea Jenkins, MD
Backup ContactCynthia Dodds, PT PhD
Outcome results
None listed